MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95004
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A peritoneal dialysis (pd) patient contact stated something broke off on the patient's pd catheter.The patient was not connected at the time of the call.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) stated during the patient's treatment, the patient was sitting in a chair and reported feeling fluid on their stomach and noticed the catheter extension set had broken off of the patient's pd catheter.A fluid leak was subsequently noted from between the catheter extension and the catheter.The pdrn stated the connection site did not leak during setup but began leaking during an unknown phase and cycle of treatment.The cause of disconnection was unknown.The pdrn confirmed there were no issues reported with the cycler or cycler set itself, and no fluid came into contact with the cycler.The pdrn confirmed there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The pdrn stated the patient clamped off the pd catheter and came into the clinic that same morning had had the 12" extension set replaced.The patient was provided prophylactic medication as part of protocol due to the fluid leak (2g vancomycin and ceftazidime) and stated the patient has remained asymptotic.Per pdrn the patient fluid was unable to be cultured due to insufficient volume of fluid obtained.Per pdrn the patient and spouse are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient stated the pd catheter extension set was replaced with another 12" extension set, and continued with peritoneal dialysis on the current cycler the following evening without issue and without reoccurrence of the reported event.The pdrn stated the extension set used was discarded and was no longer available to be returned for investigation.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Event or Problem Description
A peritoneal dialysis (pd) patient contact stated something broke off on the patient's pd catheter.The patient was not connected at the time of the call.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) stated during the patient's treatment, the patient was sitting in a chair and reported feeling fluid on their stomach and noticed the catheter extension set had broken off of the patient's pd catheter.A fluid leak was subsequently noted from between the catheter extension and the catheter.The pdrn stated the connection site did not leak during setup but began leaking during an unknown phase and cycle of treatment.The cause of disconnection was unknown.The pdrn confirmed there were no issues reported with the cycler or cycler set itself, and no fluid came into contact with the cycler.The pdrn confirmed there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The pdrn stated the patient clamped off the pd catheter and came into the clinic that same morning had had the 12" extension set replaced.The patient was provided prophylactic medication as part of protocol due to the fluid leak (2g vancomycin and ceftazidime) and stated the patient has remained asymptotic.Per pdrn the patient fluid was unable to be cultured due to insufficient volume of fluid obtained.Per pdrn the patient and spouse are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient stated the pd catheter extension set was replaced with another 12" extension set, and continued with peritoneal dialysis on the current cycler the following evening without issue and without reoccurrence of the reported event.The pdrn stated the extension set used was discarded and was no longer available to be returned for investigation.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 23065893
• Report Number: 0008030665-2025-02217
• Device Sequence Number: 21328933
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.; PD SOLUTION.; PD SOLUTION.
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 97 KG